Table 1 Study design and observation items
Aim | Skin electrode distance/electrode spacing | Observation items | Subgroups | |
|---|---|---|---|---|
Pig model | To test irreversible electroporation ablation of the breast | 3 mm in 1 pig, 5–8 mm in five pigs/electrode spacing: 1.5–2 cm | Safety and feasibility–pathological changes and imaging changes: apoptosis assays, skin and breast regeneration | IRE group: 6 pigs sham treatment group: 2 pigs. Three left breasts in each pig were ablated or processed, and the right breasts were used as controls |
Rabbit model | To test irreversible electroporation ablation of the breast with thin skin | 1 mm in 4 ablation zones and 3 mm in another 4 ablation zones Electrode spacing: 1.5–2 cm | Safety and skin architecture | 8 sessions of IRE performed in 4 rabbits |
Rabbit model with breast cancer | To test irreversible electroporation ablation of breast cancer with thin skin | 1, 3 mm and no less than 5 mm Electrode spacing: 1.5–2 cm | Changes in pathology and ultrasound: skin architecture, contrast-enhanced ultrasound and elastosonography | 4 rabbits Two breast cancer models were generated in each rabbit |